Sunshine Act reporting affects every sponsor that pays clinical investigators. The Open Payments Program requires makers of drugs, medical devices and biologics that take part in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals, including clinical investigator payments.
The law was part of a healthcare reform bill passed in March 2010, in response to calls for more transparency about financial ties between physicians and industry.
This 60-minute webinar summarizes the Open Payments requirements and offers practical answers to the situations that come up most often between sponsors and investigators, including reporting templates, exemptions and timelines for compliance and enforcement.
The Sunshine Act places clinical trial reporting duties on sponsors and physicians, and non-compliance can lead to large fines. Life science companies have to put detailed reporting in place, while healthcare providers need to anticipate how payments will appear in public reports.
This session helps drug, device and biotech manufacturers, clinical trial professionals, regulatory affairs staff and senior management plan practical steps for transparency and compliance.
The Sunshine Act places clinical trial reporting duties on sponsors and physicians, and non-compliance can lead to large fines. Life science companies have to put detailed reporting in place, while healthcare providers need to anticipate how payments will appear in public reports.
This session helps drug, device and biotech manufacturers, clinical trial professionals, regulatory affairs staff and senior management plan practical steps for transparency and compliance.
Danielle DeLucy
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she …
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